HOMED Mesh Nebulizer

K170886 · Shenzhen Homed Medical Device Co., Ltd. · CAF · Jun 21, 2018 · Anesthesiology

Device Facts

• Record ID: K170886
• Device Name: HOMED Mesh Nebulizer
• Applicant: Shenzhen Homed Medical Device Co., Ltd.
• Product Code: CAF · Anesthesiology
• Decision Date: Jun 21, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5630
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.

Device Story

Handheld, battery/AC-powered vibrating mesh nebulizer; generates aerosol by electrically activating a piezoelectric ceramic actuator (PZT) to vibrate a supporting plate and polymer mesh; liquid medication placed in 6ml medicine cup; aerosol inhaled via mouthpiece. Operated by patient or clinician in home, hospital, or sub-acute settings. Device features ON/OFF button; LED indicators for status (green=normal, orange=malfunction); automatic shut-off after 30 minutes. Firmware controls vibration frequency at ~117 kHz to maintain nebulization rate >0.25 ml/min. Provides portable, efficient medication delivery; benefits patients requiring respiratory therapy by enabling consistent aerosolization of prescribed drugs.

Clinical Evidence

Bench testing only. Comparative aerosol performance testing conducted using cascade impactors at adult (28 lpm) and pediatric (12 lpm) flow rates with Ventolin, Budesonide, and Atrovent. Metrics included MMAD, GSD, total respirable dose, coarse/fine/ultra-fine particle doses, and total delivered dose. Results showed performance substantially equivalent to the predicate. Biocompatibility testing per ISO 10993-1 and electrical safety/EMC testing per IEC 60601-1 series were also performed.

Technological Characteristics

Vibrating mesh technology; piezoelectric ceramic actuator (PZT) transducer; polymer mesh. Power: 2x AA batteries or AC adapter (100-240V). Dimensions: 77x74x48mm; weight: 80g. Connectivity: None. Software: Firmware-controlled vibration frequency (~117 kHz). Biocompatibility: ISO 10993-1 compliant. Standards: ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11.

Indications for Use

Indicated for patients 5 years and older in home, hospital, and sub-acute care settings for inhalation of physician-prescribed liquid medications, excluding Pentamidine.

Regulatory Classification

Identification

A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.

Predicate Devices

• Omron NE-U22 (K062263)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box. To the right of that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 21, 2018

Shenzhen Homed Medical Device Co,.Ltd. Shengming Shi Manager of Technical Regulation Department 3rd Floor, Block 2, Longgu Industrial Zone, Huawang Road Tongsheng Community, Dalang Street, Longhua New District Shenzhen, 518109 Cn

Re: K170886

Trade/Device Name: HOMED Mesh Nebulizer Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF Dated: May 22, 2018 Received: May 23, 2018

## Dear Shengming Shi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Amy K. Levelle -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

## K170886

Device Name

HOMED Mesh Nebulizer (Model JLN-MBXXX; XXX: 001~005)

Indications for Use (Describe)

The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.

Type of Use (Select one or both, as applicable)

| XX Prescription Use (Part 21 CFR 801 Subpart D) | |
|-------------------------------------------------|--|
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

EF PSC Publishing Services [phone]

{3}------------------------------------------------

## K170886

Shenzhen Homed Medical Device Co., Ltd 3rd Floor, Block 2, Longgu Industrial Zone, Huawang Road, Tongsheng Community Dalang Street, Longhua New District Shenzhen 518 10 9, PRC

| Official Contact: | Shengming Shi<br>Manager of Technical Regulation Department<br>Tel – 011 0755-29821675 |
|----------------------------|-----------------------------------------------------------------------------------------------------|
| Proprietary or Trade Name: | HOMED Mesh Nebulizer |
| Common/Usual Name: | Nebulizer (Direct Patient Interface) |
| Classification Name: | Nebulizer (Direct Patient Interface)<br>Product Classification - CAF<br>21 CFR 868.5630<br>Class II |
| Predicate Devices: | K062263 – Omron NE-U22 |

## Device Description:

The HOMED Mesh Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.

## Components

The Medicine Cup contains the nebulizing module where aerosol will be generated. Prescribed medication is placed in the Cup, nebulized and inhaled via the integral mouthpiece.

The Medicine Cup is single patient, multi-use. Cleaning is performed after each use by rinsing with distilled water and disinfected via immersion in boiled water for 10 minutes. The performance met its specification criteria of 90 days.

The cup medication capacity is 6 ml.

The Main Unit contains the 2 "AA" batteries or AC Adaptor and firmware to control the vibrating mesh module in the Medicine Cup.

The HOMED Mesh Nebulizer aerosolizes upon turning on by pressing the ON/OFF button and turns off by pressing again or automatically after treatment completion in 30 minutes. To monitor nebulization status and device operating condition, there are different LED colors shown. Normal working condition is indicated by a green while an orange color signifies a malfunction.

There is one model of the subject device, the housing may be offered in various colors, but the unit is fundamentally identical.

## Indications for Use:

The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for

{4}------------------------------------------------

## 510(k) Summary Page 2 of 7 June 21, 2018

Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings.

## Principle of Operation / Technology

The HOMED Mesh Nebulizer operates by electrically activating piezoelectric ceramic actuator (PZT) which then transduces the vibration generated to the adjacent supporting plate and polymer mesh bearing numerous apertures. The vibration actively pushes out the liquid medication by physically breaking surface tension of the solution through mesh holes thereby achieving final nebulization. Aerosol generation can subsequently be modulated the vibration frequency that is controlled by the firmware stored within Main Unit to maintain a frequency of approximate 117 kHz, nebulization rate of > 0.25 ml/min and a power consumption of <1.5 W.

| Features | Mesh Nebulizer |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The HOMED Mesh Nebulizer is an ultrasonic vibrating mesh nebulizer system designed to aerosolize physician-prescribed liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and older in the home, hospital, and sub-acute care settings |
| Environment of Use | liquid medications for inhalation to a patient except for Pentamidine. The device may be used with patients 5 years and |
| Patient Population | older in the home, hospital, and sub-acute care settings |
| Vibrating mesh technology | Yes |
| Software driven | Yes - firmware |
| Patient Interface | Mouthpiece |
| Nebulizer components cleanable | Medicine Cup and Mouthpiece |
| Operating conditions | 10°C to 40°C 30% to 75% RH |
| Storage conditions | -20°C to 70°C, 20% to 80% RH |
| Power Sources | 2- “AA” Alkaline batteries – 3 V<br>AC Adapter - 100-240 V, 50/60Hz<br>Output 1.5 V, 1 A |
| Dimensions | 77 mm (L) x 74 mm (W) x 48 mm (H) |
| Weigh | 80 gr without batteries |
| MMAD | < 5 microns |
| Nebulization rate | ≥ 0.25 ml / min |
| Medication capacity | 6 ml |

## Table 1 - Performance Specifications

## Comparison to Predicate

Tables 2 provides a comparison of the proposed device to the predicate.

{5}------------------------------------------------

# 510(k) Summary
Page 3 of 7
June 21, 2018

| Table 2 – Comparison of Proposed vs. Predicate Device | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | Predicate<br>Omron NE-U22<br>K062263 | Proposed<br>Portable Nebulizer |
| Indications for use | The Omron NE-U22 is an ultrasonic<br>(vibrating mesh) nebulizer system designed<br>to aerosolize liquid medications for<br>inhalation by the patient. | The HOMED Mesh Nebulizer is an<br>ultrasonic vibrating mesh nebulizer system<br>designed to aerosolize physician-<br>prescribed liquid medications for<br>inhalation to a patient except for<br>Pentamidine. The device may be used with<br>patients 5 years and older in the home,<br>hospital, and sub-acute care settings. |
| Patient Population | The device may be used with pediatric and<br>adult patients | |
| | | |
| Environment of Use | home, hospital, and sub-acute care settings | |
| Contraindications | It is not intended for use with<br>Pentamidine. | It is not intended for use with Pentamidine. |
| Principle of Operation | Vibrating mesh | Vibrating mesh |
| Aerosolization | Continuous during inhalation and<br>exhalation | Continuous during inhalation and<br>exhalation |
| Compressed gas source | None needed | None needed |
| Reservoir volume | 7 ml | 6 ml |
| Nebulization rate | 0.25 ml/min to 0.9 ml/min | > 0.25 ml/min |
| Duration of Use | Single patient, multi-use | Single patient, multi-use |
| Nebulizer components<br>cleanable | Yes | Yes |
| Software driven | No | Yes |
| Power source | 2 - “AA” Battery | 2 - “AA” battery<br>AC Adaptor |
| Power consumption | 1.5 W | < 1.5 W |
| Weight | 97 gm w/o batteries | 80 gm w/o batteries |
| Dimensions (mm) | 51 x 38 x 104 | 77 x 74 x 48 |
| Operating Conditions | 0 to 45°C / 30-85% RH | 10 to 40°C / 30-75% RH |
| Storage Conditions | -25 to + 70°C / 10-90% RH | -20 to + 70°C / 20-70% RH |
| User interface | On/Off switch<br>LED indicators | On/Off switch<br>LED indicators |
| Standards met | ES60601-1<br>IEC 60601-1-2 | ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-6<br>IEC 60601-1-11 |
| | Performance | |
| Materials per ISO<br>10993-1 | External Communicating<br>(Indirect gas pathway)<br>Tissue / Bone / Dentin communicating<br>Duration of Use – permanent (> 30 days)<br>And<br>Surface Contact<br>Mucosal membrane<br>Duration of Use – permanent (> 30 days) | External Communicating<br>(Indirect gas pathway)<br>Tissue / Bone / Dentin communicating<br>Duration of Use – permanent (> 30 days)<br>And<br>Surface Contact<br>Mucosal membrane<br>Duration of Use – permanent (> 30 days) |
| MMAD | MMAD, GSD, Total Respirable Dose, and Total Dose were substantially equivalent to<br>the predicate. | |
| GSD | | |
| Total Respirable Dose | | |
| Total Dose | | |
| Features | Predicate<br>Omron NE-U22<br>K062263 | Proposed<br>Portable Nebulizer |
| Software | | |
| Level of Concern | Moderate | Moderate |
| Device Specific | Yes | Yes |
| Dependent on external<br>devices | No | No |
| Signals | LED and tone sounds | LED and tone sounds |

## Table 2 – Comparison of Proposed vs. Predicate Device

{6}------------------------------------------------

#### 510(k) Summary Page 4 of 7 June 21, 2018

## Substantial Equivalence Discussion

The HOMED Mesh Nebulizer is viewed as substantially equivalent to the predicate device because:

Indications for Use - The proposed indications for use are to aerosolize commonly prescribed medications.

Discussion - The indications for use are identical for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.

Patient Population – The patient population of adult and pediatric (defined by the prescribed medication) patients that is consistent with the indications for the aerosol medication. This is similar to the predicate - K062263 - Omron NE-U22 nebulizer.

Discussion - The patient population is similar for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.

Environment of Use – The proposed environments of use are common and usual for handheld nebulizers, namely Hospital/institutional settings, home care use, schools and long term care facilities.

Discussion - The environment of use is similar for the proposed device and the predicate -K062263 – Omron NE-U22 nebulizer.

Technology - The design as a vibrating mesh nebulizer which is the similar principle of operation.

Discussion - The technology is similar for the proposed device as compared to the predicate -K062263 – Omron NE-U22 nebulizer.

## Summary of Non-Clinical Performance Testing

We performed a number of non-clinical tests to demonstrate that the HOMED Mesh Nebulizer is equivalent to the predicate K062263 - Omron NE-U22 nebulizer.

- Shelf-life, Useful-life, Simulated Life Cycle testing ●
- Cleaning ●
- Electrical Safety, EMC, EMC ●
- Particle Characterization per Cascade Impactor

## Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical safety and EMC testing were conducted on the device. Testing established that, with respect to electrical safety, the device meets the applicable requirements of: (1) IEC 60601-1:2012; (2) IEC 60601-1-2:2014; (3) IEC 60601-1-11:2012.

{7}------------------------------------------------

## 510(k) Summary Page 5 of 7 June 21, 2018

## Software Verification and Validation Testing

Verification and validation testing was conducted in accordance with, and documentation was provided as recommended by FDA's Guidance 337, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". The software for this device is of a "moderate" level of concern, since a failure or latent flaw in the software could lead to a delay in delivery of appropriate medical care.

## Biocompatibility

The materials in patient / drug contact are characterized as:

- . External Communicating (Indirect gas pathway)
- Tissue / Bone / Dentin communicating ●
- . Duration of Use – permanent (> 30 days)

And

- Surface Contact ●
- Mucosal membrane ●
- Duration of Use permanent (> 30 days) .

Discussion - We performed ISO 10993-1 tests to support biocompatibility. They included:

- Cytotoxicity ●
- Sensitization ●
- Intracutaneous Reactivity ●
- Irritation
- Sub-chronic Systemic toxicity
- Acute Systemic Toxicity
- Pyrogen
- Genotoxicity
- Implantation
- Gas Emission VOC plus Inorganic compounds CO. CO2, and Ozone ●
- . PM25

Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended.

## Particle Characterization

Comparative aerosol characterization (particle size distribution) performed between the subject and predicate device. The following tables summarize the results, in all the results very similar compared to that of the predicate.

| Features | Predicate | Proposed |
|----------------------------------------------------------------------|---------------------|----------------|
| | Omron NE-22 K062263 | Mesh Nebulizer |
| Particle Characterization per Cascade Impactor @ 28 lpm - Adult Flow | | |
| Particle size (MMAD) | | |
| Ventolin | 2.850-3.148 | 2.792-2.922 |
| Budesonide | 2.686-2.761 | 2.532-2.577 |
| Atrovent | 2.761-3.103 | 2.412-2.552 |
| Geometric Std. Dev. (GSD) | | |
| Ventolin | 2.814-3.011 | 2.818-2.866 |
| Budesonide | 3.112-3.221 | 3.115-3.165 |
| Atrovent | 2.824-3.070 | 2.746-2.845 |

## Table 3 - Comparative Aerosol Performance - Adult Flow Rate - 28 Ipm

{8}------------------------------------------------

| 510(k) Summary | | |
|-------------------------------------------|------------|------------|
| Page 6 of 7 | | |
| June 21, 2018 | | |
| Total Respirable Dose (0.5-5 $\mu$ ) / % | | |
| Ventolin | 62.1-64.9% | 64.8-67.2% |
| Budesonide | 63.4-65.4% | 64.0-65.7% |
| Atrovent | 61.3-67.0% | 67.3-69.1% |
| Coarse Particle Dose (>4.7 $\mu$ ) / % | | |
| Ventolin | 33.1-37.2% | 30.4-32.2% |
| Budesonide | 28.2-31.0% | 26.8-29.7% |
| Atrovent | 12.6-38.6% | 23.1-25.9% |
| Fine Particle Dose (<4.7 $\mu$ ) / % | | |
| Ventolin | 62.6-66.4% | 68.0-69.6% |
| Budesonide | 69.0-87.5% | 70.3-73.2% |
| Atrovent | 61.6-76.3% | 74.0-76.9% |
| Ultra-fine Particle Dose (< 1.0 $\mu$ ) / | | |
| %Ventolin | 3.4-5.0% | 5.0-5.4% |
| Budesonide | 7.8% | 8.9-9.2% |
| Atrovent | 6.8-8.4% | 9.2-10.6% |
| Total Delivered Dose ( $\mu$ g) / % | | |
| Ventolin | 21.3-23.6% | 22.1-22.8% |
| Budesonide | 17.5-19.6% | 18.0-18.6% |
| Atrovent | 17.6-19.1% | 18.0-18.5% |
| 95% confidence intervals | | |

## Table 4 – Comparative Aerosol Performance – Pediatric Flow Rate – 12 Ipm

| Features | Predicate | Proposed |
|--------------------------------------------------------------------------|---------------------|----------------|
| | Omron NE-22 K062263 | Mesh Nebulizer |
| Particle Characterization per Cascade Impactor @ 12 lpm – Pediatric Flow | | |
| Particle size (MMAD) | | |
| Ventolin | 2.996-3.575 | 3.177-3.388 |
| Budesonide | 2.778-2.997 | 2.739-2.850 |
| Atrovent | 2.782-3.077 | 2.805-2.920 |
| Geometric Std. Dev. (GSD) | | |
| Ventolin | 2.533-2.736 | 2.450-2.767 |
| Budesonide | 2.813-2.964 | 2.933-3.011 |
| Atrovent | 2.778-3.019 | 2.580-2.746 |
| Total Respirable Dose (0.5-5 $\mu$ ) / % | | |
| Ventolin | 55.7-64.5% | 55.5-62.6% |
| Budesonide | 60.1-63.3% | 61.3-63.2% |
| Atrovent | 54.1-73.6% | 65.3-69.8% |
| Coarse Particle Dose (>4.7 $\mu$ ) / % | | |
| Ventolin | 33.9-43.7% | 37.2-39.3% |
| Budesonide | 28.8-39.0% | 30.7-32.1% |
| Atrovent | 6.0-57.6% | 26.6-30.5% |
| Fine Particle Dose (<4.7 $\mu$ ) / % | | |
| Ventolin | 56.3-66.1% | 60.6-62.8% |
| Budesonide | 61.0-71.1% | 67.9-69.3% |
| Atrovent | 42.4-93.5% | 69.5-73.4% |
| Ultra-fine Particle Dose (< 1.0 $\mu$ ) /<br>/ | | |
| %Ventolin | 2.1-3.0% | 2.2-2.6% |
| Budesonide | 6.7-7.4% | 7.8-8.7% |
| Atrovent | 4.0-6.5% | 5.1-6.9% |
| Total Delivered Dose ( $\mu$ g) / % | | |
| Ventolin | 20.8-22.1% | 21.1-21.9% |
| Budesonide | 15.9-16.8% | 16.1-16.8% |
| Atrovent | 15.0-17.6% | 16.0-16.7% |
| 95% confidence intervals | | |

{9}------------------------------------------------

## 510(k) Summary Page 7 of 7 June 21, 2018

Particle size characterization (MMAD) was verified after two years of real-time aging using both cascade impactor technique.

## Substantial Equivalence Conclusion

As detailed, the indications for use, patient population, environment of use, technology or principle of operation and performance are substantially equivalent.

The differences between the proposed HOMED Mesh Nebulizer and the predicate - K062263 -Omron Model NE-U22 based upon the comparative performance testing we can conclude that the proposed device can be determined to be substantially equivalent to the predicate.